FLOWSPI 250 MG CAPSULES HARD, URSODEOXYCHOLIC ACID 250 MG HARD CAPSULES - patient leaflet, side effects, dosage

1. what ursodeoxycholic acid is and what it is used for

Ursodeoxycholic acid contains the active substance ursodeoxycholic a­cid.

Ursodeoxycholic acid is a chemical present naturally in the body and it helps to control the amount of cholesterol in the blood.

Ursodeoxycholic acid is used:

• – to dissolve gallstones caused by excess cholesterol in the gall bladder (in patients for whom surgery is not an option), where the gallstones are not visible on a plain X-ray (gallstones that are visible will not dissolve) and not more than 15 mm in diameter. The gall bladder should still be working despite the gallstone(s).

• – for the treatment of a condition where the bile ducts in the liver become damaged leading to a build-up of bile. This may cause scarring of the liver. The liver should not be so damaged that it is not functioning properly. This condition is called primary biliary cholangitis.

• – to treat children and adolescents, aged 6 years to less than 18 years, who have liver problems associated with cystic fibrosis.

2. what you need to know before you take ursodeoxycholic acid

Do not take Ursodeoxycholic acid:

• – if you are allergic to ursodeoxycholic acid or any of

the other ingredients of this medicine (listed in section 6);

• – if you have acute inflammation of the gall bladder or

biliary tract;

• – if you have an obstruction of the biliary tract (blockage

of the common bile duct or a cystic duct);

• – if you suffer from frequent cramp-like pains in the

upper abdomen (biliary colic);

• – if you have gallstones caused by a build-up of calcium

that are visible on an X-ray;

• – if your gall bladder does not work properly;

Children with a condition where the bile ducts have not developed correctly (biliary atresia), who have had an operation (portoenterostomy) to treat this which has been unsuccessful or who have not had recovery of good bile flow, should not take ursodeoxycholic a­cid.

Ask your doctor about any of the conditions mentioned above. You should also ask if you have previously had any of these conditions or if you are unsure whether you have any of them.

Warning and precautions

Talk to your doctor or pharmacist before taking ursodeoxycholic a­cid.

Ursodeoxycholic acid must be used under medical supervision.

Your doctor should test your liver function regularly every 4 weeks for the first 3 months of treatment. After this time, it should be monitored every 3 months.

Inform your doctor immediately if you have diarrhoea as this may require a reduction in the dose or stopping the treatment.

Other medicines and Ursodeoxycholic acid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even if they are obtainable without a prescription. Treatment with ursodeoxycholic acid may still be allowed. Your doctor will know what is right for you.

A reduction in the effects of the following medicines is possible when taking ursodeoxycholic a­cid:

• – colestyramine, colestipol (to lower blood lipids) or antacids (to relieve indigestion or heartbum) containing aluminium hydroxide or smectite (aluminium oxide).

If you must take medicines that contain any of these ingredients, you should take these at least two hours before or after ursodeoxycholic a­cid.

• – ciprofloxacin and dapsone (antibiotics), nitrendipine (used to treat high blood pressure). It may be necessary for your doctor to change the dose of these medicines.

• – charcoal (used to treat indigestion and poisoning).

An increase in the effects of the following medicines is possible when taking ursodeoxycholic a­cid:

• – ciclosporin (to reduce the activity of the immune system). If you are being treated with ciclosporin, your doctor should check the amount of ciclosporin in your blood.

Your doctor will adjust its dose, if necessary.

Inform your doctor if you are taking any blood cholesterol lowering medicines such as clofibrate or medicines that contain oestrogen (hormone replacement therapy or the contraceptive pill), especially if you are taking ursodeoxycholic acid for the dissolution of gallstones, as they may stimulate the formation of gallstones.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fertility

Use a reliable method of contraception – non-hormonal contraceptives (barrier methods) or low-oestrogen oral contraceptives are recommended. If you are taking this medicine for dissolution of gallstones, only use non-hormonal contraceptives, as hormonal oral contraceptives may stimulate the formation of gallstones.

Pregnancy

You should not take this medicine during pregnancy unless your doctor thinks it is absolutely necessary. Use of ursodeoxycholic acid during the first three months of pregnancy may affect the foetus.

Check that you are not pregnant before taking this medicine.

Breast-feeding

Do not take this medicine if you are breast-feeding as the active ingredient in this medicine may pass into breast milk. If treatment with ursodeoxycholic acid is necessary, then stop breast-feeding.

Driving and using machines

No particular precautions are necessary.

3. how to take ursodeoxycholic acid

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the capsules whole with a drink of water or other liquid. Take the capsules regularly.

The daily dose below serves as an example of how you can take the capsules.

Dosage

Use in patients with damage to liver tissue by impaired bile flow (Primary Biliary cholangitis)

Your doctor will determine your dose depending on your body weight. During the first 3 months of treatment, you should take 3–7 capsules in divided doses throughout the day. As the liver function improves, the total daily dose can be taken once, in the evening.

Primary Biliary cholangitis Stage I-HI
Daily dose (total number of capsules)	First 3 months (how many capsules to take throughout the day)			Subsequently
	Morning	Afternoon	Evening	Evening (once daily)
3 capsules	1	1	1	3
4 capsules	1	1	2	4
5 capsules	1	2	2	5
6 capsules	2	2	2	6
7 capsules	2	2	3	7

Primary Biliary cholangitis Stage IV
Daily dose (total number of capsules)	How many capsules to take throughout the day
	Morning	Evening
2 capsules	1	1
3 capsules	1	2

If you do not experience any problems at this dose (after blood tests and/or according to an evaluation), your doctor will prescribe you a higher dose (dosage in accordance with

Dimension – 180 × 420 mm

the treatment of stage I-III). Duration of treatment Your doctor will determine the duration of treatment. It may be necessary to get your blood checked regularly by the laboratory. Ursodeoxycholic acid may be continued indefinitely in cases of primary biliary cholangitis. Note: In patients with primary biliary cholangitis, the symptoms may worsen at the start of treatment, for example the itching may increase. This only occurs in rare cases. If this happens, therapy can be continued with a lower daily dose of ursodeoxycholic acid. Each week, your doctor will then gradually increase the daily dose, until you reach the required dose. Use in patients with gallstones The recommended dose is approximately 10 mg of ursodeoxycholic acid per kg body weight per day, taken as follows:			Not known (frequency c available data) – being sick (vomiting) – in patients with cirrhc at the beginning of th ruled out. – in patients with stage there may be an incre certain enzymes (alka glutamyltransfe­rase) Reporting of side effect If you get any side effect nurse. This includes any this leaflet. You can also report sic Scheme at agency’s we or search for MHRA Yell App Store. By reporting	annot be estimated from the feeling sick (nausea). sis, aggravation of pruritus (itching) e treatment cannot be completely IV primary biliary cholangitis, ase in the concentration of line phosphates, gammamd bilirubin. s s talk to your doctor, pharmacist or possible side effects not listed in e effects directly via Yellow Card □site: ow Card in the Google Play or Apple » side effects you can help provide safety of this medicine. jxycholic acid f the sight and reach of children. after the expiry date which is stated arton after ‘EXP’. The expiry date lat month. oes not require any special storage nedicines via wastewater or ur pharmacist how to throw away use. These measures will help k and other information acid contains is ursodeoxycholic acid. Each mg ursodeoxycholic acid. are: ddone (Kollidon K-30) (E1201), e (E487), maize starch, magnesium (E441), titanium dioxide (E 171). acid looks like and contents of the e white hard gelatin capsules (size off white powder. e in colourless PVC film with eked in cardboard cartons. available in packs of20, 28, 30, 50, ules. s marketed. m Holder and Manufacturer ____ m Holder 1. Ipits Lane, Watford,
	Patients with gallstones		more information on the

5. how to store ursodet

Keep this medicine out o

Expiry date

Do not use this medicine on the blister label and c refers to the last day of tl Storage

This medicinal product c conditions.

Disposal

Do not throw away any i household waste. Ask yo medicines you no longer protect the environment.

• 6. Contents of the pac What Ursodeoxycholic – The active substance capsule contains 250

• – The other ingredients – Capsule contents: pox sodium lauryl sulphat stearate (E572).

• - Capsule shell: gelatin

What Ursodeoxycholic pack

Ursodeoxycholic acid ar ‘0’) containing a white t( The capsules are availab aluminium blister foil pa Ursodeoxycholic acid is 56, 60, 100 and 120 caps Not all pack sizes may b

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Body Weight (kg)

How many capsules to take in the evening before bedtime

Up to 60 kg

2 capsules

61–80 kg

3 capsules

81–100 kg

4 capsules

More than 100 kg

5 capsules

Duration of treatment

It generally takes 6–24 months to dissolve gallstones. The duration of your treatment depends on the size of the existing gallstones at the beginning of the treatment. Even if your symptoms have disappeared, you should continue with the treatment. Stopping treatment may result in the extension of the total treatment time. After the gallstones have been dissolved, the treatment should be continued for 3–4 months. If there is no reduction in the size of the gallstones after 12 months, therapy should be stopped.

Every 6 months, your doctor should check whether the treatment is working. At each of these follow-up examinations, it should be checked whether a build-up of calcium causing hardening of the stones has occurred since the last time. If this happens, your doctor will stop the treatment.

If you feel that the effect of ursodeoxycholic acid is too strong or too weak, talk to your doctor or pharmacist.

Use in children with cystic fibrosis aged 6 years to less than 18 years

The recommended dose is 20 mg per kg body weight per day in 2–3 divided doses, with a further increase to 30 mg per kg body weight per day if necessary.

There are no age limits to the use of ursodeoxycholic acid. The administration of ursodeoxycholic acid is based on body weight and the medical condition. If the patient cannot swallow capsules or has a bodyweight below 47 kg, other pharmaceutical forms (suspension) are available.

If you take more Ursodeoxycholic acid than you should

If you or anyone else take too many capsules, seek

immediate medical attention. Hertfordshire WD18 9SS

United Kingdom

If you forget to take Ursodeoxychohc acid

Do not take a double dose to make up for a forgotten dose.

Strides Pharma UK Ltd.

If you stop taking Ursodeoxycholic acid TT.. „ _ .

J F 6 3 Umt 4, Metro Centre, Tolpits

Always speak to your doctor before you decide to interrupt Watford, Hertfordshire, WD1 treatment with ursodeoxycholic acid or to stop your United Kingdom

treatment early.

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If you have any further questions on the use of this medicine,

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ask your doctor, pharmacist or nurse.

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4. possible side effects                                                                 tt ,

Hard Cap Like all medicines, this medicine can cause side effects, Netherlands' Ursodeox

although not everybody gets them. harde cap

Contact your doctor immediately if you experience any United Kingdom: Ursodeox

of the following symptoms after taking Ursodeoxycholic Hard Cap

acid: This leaflet was last revised

Common side effects (may affect up to 1 in 10 people): – soft, loose stools or diarrhoea. Inform your doctor immediately if you have persistent diarrhoea, as this may require a reduction in the dose of your medicine. If you do suffer from diarrhoea, make sure you drink enough liquids to replace your fluid and salt balance.

Diarrhoea may also occur as a result of overdose.

Very rare side effects (may affect up to 1 in 10,000 people): – during the treatment of primary biliary cholangitis: severe right-sided upper abdominal pain, severe worsening of liver scarring – this partially improves after treatment is stopped.

• – hardening of gallstones due to build up of calcium. There are no additional symptoms of this but it will show up in tests.

• – nettle rash (urticaria).

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Dimension – 180 × 420 mm one BackSide

ARTWORK DETAIL LABEL

Ursodeoxycholic acid 250mg Hard Capsules – Pack Insert – SPUK – 1041999.indd 2

10/27/2020 11:30:48 AM